Suction/Irrigation Y Tubing Set

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K922655 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Core Dynamics Laparoscipic Irrigation Pump

  Class II

  FDA 510(k) K931138 Active Cleared 7 Sep 1993

• Core Disposable Insufflation Tubing

  Class II

  FDA 510(k) K901413 Active Cleared 24 Sep 1990

• Laparoscopic/Suction/Irrigation Probe

  Class II

  FDA 510(k) K935826 Active Cleared 18 May 1994

• Entree Thoracoscopy Cannula Set

  Class II

  FDA 510(k) K932022 Active Cleared 28 Jul 1993

• Laparoscopic Knitter

  Class II

  FDA 510(k) K955490 Active Cleared 22 Jan 1996

• Entree Cannula Fascia Anchors

  Class I

  FDA 510(k) K932021 Active Cleared 11 Jan 1994

See all devices from Core Dynamics, Inc. →

• What is the Core Dynamics Y tubing set designed for?

  This Y tubing set is specifically designed for simultaneous suction and irrigation during endoscopic or urological procedures. Its dual-lumen configuration allows separate pathways for suction and irrigation, helping maintain a clear field of view by managing fluids effectively during interventions.

• How is the Core Dynamics Y tubing set supplied and what are its sterility and usage guidelines?

  The set is supplied as a single-use, sterile device, intended exclusively for clinical use in settings like endoscopy suites or urology operating rooms. Sterility is maintained through standard single-use medical device manufacturing processes, ensuring it is uncontaminated upon opening. It must not be reused after a single procedure.

• Is this tubing set reusable or intended for single-use only?

  The Core Dynamics Y tubing set is explicitly intended for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and potentially introduce contamination risks during medical procedures.

• What regulatory approval does this device hold?

  This device holds FDA 510(k) clearance under the reference number K922655. It is classified under product code GCJ for gastrointestinal and urological procedures and is deemed substantially equivalent to a predicate device. The clearance was granted by the Gastroenterology and Urology advisory committees.

• What are the key features of the Y tubing configuration in this set?

  The Y-shaped tubing configuration provides two distinct pathways: one for suction and another for irrigation. This dual-lumen design allows clinicians to simultaneously remove fluids and introduce irrigation solutions, which is particularly useful in procedures requiring precise fluid management to maintain visibility and procedural efficiency.